510(k) K193358

MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) by Beckman Coulter, Inc. — Product Code LTT

K193358 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)". The FDA issued a decision of Substantially Equivalent on March 3, 2020. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.